The present invention generally relates to a compression device for treating various circulatory disorders and generally improving circulation for users such as athletes, people with wounds, and people who have to sit for a long period of time. More specifically the present invention relates to a compression device with inflatable bladders and a control system for applying compressive pressure to a body part of a living being.
The inventive compression device may be used to treat any or all of the following circulatory disorders: deep vein thrombosis (DVT), lymphedema, chronic venous insufficiency (CVI), varicose veins, and peripheral arterial disease (PAD).
Deep Vein Thrombosis is a blood clot that can form in a person's legs and sometimes move to his or her lungs, where it could potentially be fatal. DVT is usually caused by immobility. DVT is commonly treated with compression devices. The inventive compression device may be used in DVT prevention, although a user should consult a physical before doing so, as any compression device could release a dangerous blood clot.
DVT kills 200,000 Americans each year, more than AIDS and breast cancer combined. 74% of Americans do not know of the condition or symptoms. This little known condition hospitalizes 600,000 people each year. About 2 million people in the United States have a pulmonary embolism each year and more than 10% die from it. Nine out of ten cases of pulmonary embolism are caused by blood clots that form in the legs and then travel to the lungs. Most who die from DVT do so within 30-60 minutes after symptoms start. Pulmonary embolisms occur equally in men and women. The risk of having a pulmonary embolism doubles for every 10 years after the age of 60.
Lymphedema is an abnormal build up of lymph fluid which occurs when a lymph system becomes blocked or impaired. Usually, the affected area involves an extremity. Lymphedema causes the extremity to swell and become heavy and limited in mobility and function. Lymphedema is commonly treated with compression devices. Primary lymphedema is present at birth and effects 2,000,000 people worldwide, effects 10 women to every 1 man, and effects 10 legs to every 1 arm.
Secondary lymphedema is caused by scarring, injury to, or removal of lymph nodes. Secondary lymphedema affects 25,000,000 people worldwide and 2.5 million in the United States.
Chronic venous insufficiency (CVI) is a condition where blood pools in the veins of the lower legs. The veins return blood to the heart from all the body's organs. To do this the calf muscles and the muscles in the feet need to contract with each step to squeeze the veins and push the blood upward. To keep the blood flowing up, and not back down, the veins contain one-way valves. Chronic venous insufficiency occurs when these valves become damaged, allowing the blood to leak backward and pool. Massage techniques are currently used for treatment, along with pressure stockings and compression. Sometimes bypass surgery or valve repair is required.
CVI is a significant public health problem in the United States. About 2-5% of all Americans have change associated with CVI. Approximately 24 million Americans have varicose veins and approximately 6 million Americans have skin changes associated with CVI. Venous stasis ulcers affect approximately 500,000 people. The mean incidence for hospital admission for CVI is 92 per 100,000 admissions. CVI can lead to leg ulcers which can be severe and are responsible for 100,000 cases of disability in the United States alone. Incidences of CVI typically occur in women aged 40-49 and men aged 70-79.
Varicose veins are swollen veins that you can see through the skin. They often look blue, bulging, and twisted. Left untreated, varicose veins may worsen over time. Large varicose veins can cause aching and feelings of fatigue as well as skin changes like rashes, redness, and sores. There are three kinds of veins in a person's legs: the superficial veins, which lie closest to the skin, the deep veins, which lie in groups of muscles, and perforating veins, which connect the superficial veins to the deep veins. The deep veins lead to the vena cava, the body's largest vein, which runs directly to the heart. Varicose veins occur in the superficial veins in your legs.
When a person is in the upright position, the blood in his or her leg veins must work against gravity to return to the heart. To accomplish this, the leg muscles squeeze the deep veins of the legs and feet. One-way flaps, called valves, in the veins keep blood flowing in the right direction. When the leg muscles contract, the valves inside the veins open. When the legs relax, the valves close. This prevents blood from flowing in reverse, back down the legs. The entire process of sending blood back to the heart is called the venous pump. Varicose veins are commonly treated with compression devices, sclerotherapy, ablation, laser treatment, or vein stripping.
As many as 40 million Americans, most of them women, have varicose veins. 50% of all women will suffer from varicose veins by their mid-50's.
When the arteries in the legs become blocked, the legs do not receive enough blood or oxygen. This may be due to a condition called peripheral artery disease (PAD), sometimes called leg artery disease. PAD is commonly treated by lifestyle changes, compression devices, medication, exercise, angioplasty/stenting, bypass surgery, endarterectomy, or amputation. One in three people age 70 or older has PAD. PAD affects about 8 million Americans. Persons with PAD also have four to five times higher risk of a heart attack or stroke.
The above conditions affect tens of millions of people. One common treatment opportunity is using compression devices. Currently there are several antiquated and differing compression devices for each condition.
The inventor has recognized that certain embodiments of the compression devices disclosed herein can treat all of these conditions. In addition, the compression devices disclosed herein can be used for preventative purposes, such as when the user has to sit for a long period of time, like on an airplane. In addition, the compression device disclosed herein can be used in sports medicine, as a circulatory assistant (a) to improve removal of lactic acid after a workout by improving circulation; (b) to promote healing and recovery time after workouts by minimizing muscle micro-hemorrhaging; (c) to increase circulation to reduced blood pooling and provide nourishment and oxygen to stressed muscles; and (d) to reduce the chance for cramping. Moreover, the compression devices disclosed herein can be used to treat and prevent chronic wounds, especially wounds that are subsisting because of poor circulation (like venous ulcer), because healing such wounds can benefit from enhanced circulation.
One prior art compression device is disclosed in U.S. Pat. No. 6,786,879. This device includes a control unit that includes an air compressor and a valve manifold that is controlled by a microprocessor. The microprocessor may control the valves in several different operating modes. The operating mode is selected depending upon the different compression sleeves to which the control unit is connected. Up to two compression sleeves may be simultaneously connected to the control unit where each compression sleeve may have four chambers. Eight valves in the control unit are coupled to the four chambers of each of the two compression sleeves using eight tubes. With four tubes running to each compression sleeve, there is an increased likelihood of getting the tubes tangled or pinched. Each of the valves is discreetly electrically coupled to the microprocessor. Different compression sleeves are used for each form of treatment.